CN110251607A - A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation and preparation method thereof - Google Patents

A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation and preparation method thereof Download PDF

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Publication number
CN110251607A
CN110251607A CN201910669853.7A CN201910669853A CN110251607A CN 110251607 A CN110251607 A CN 110251607A CN 201910669853 A CN201910669853 A CN 201910669853A CN 110251607 A CN110251607 A CN 110251607A
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preparation
added
compound preparation
spare
extracting solution
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斯拉甫·艾白
马芹
周凡
范文玺
赵如月
陈伟
王晓敏
刘利
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HUASHIDAN PHARMACEUTICAL RESEARCH Co Ltd XINJIANG
Xinjiang Huashidan Pharmaceutical Res Co Ltd
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HUASHIDAN PHARMACEUTICAL RESEARCH Co Ltd XINJIANG
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Abstract

The present invention relates to provide a kind of Traditional Chinese medicine for relieving vision fatigue compound preparation and preparation method thereof, the compound preparation is by raw material fructus lycii, mulberry leaf, puncture vine, chrysanthemum, Chinese yam, and oral solution or tablet is made in auxiliary material honey, white granulated sugar, sucrose, stevioside, lactose, potassium sorbate, essence, dextrin, starch, superfine silica gel powder, microcrystalline cellulose, sodium carboxymethylcellulose, Aspartame, magnesium stearate and crospovidone.Compound preparation of the present invention has kidney and spleen invigorating, and calming the liver and improving eyesight mitigates the effect of visual fatigue.Suitable for amblyope, as can the long period takes, asthenopia symptom can be significantly improved and safety is without side-effects.

Description

A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation and preparation method thereof
Technical field
The present invention relates to Traditional Chinese medicine for relieving vision fatigue compound preparations and preparation method thereof.
Background technique
Visual fatigue, also known as asthenopia are a kind of ophthalmology common diseases, can cause that eye is dry, eye is puckery, eye is sour swollen, blurred vision Even visual impairment.It is popularized with the development of science and technology with the quickening of work rhythm and a large amount of of video terminal, the hair of visual fatigue Sick rate is in the trend being gradually increasing, and has seriously affected the quality of life of patient.
The factor to affect vision in daily life is complicated: (1) eyesight ametropia factor leads to long sight, myopia or astigmatism Problem;Especially easily cause ametropia problem in current all kinds of excess eye-usings or the influence of viewed light problem.(2) crystalline lens is muddy Turbid influence.(3) cornea sickness influence.(4) eye nutritional deficiency also generates certain influence to vision.
Traditional Chinese medicine is early to have certain research to record visual fatigue problem in ancient times, and is divided into according to pathological factor 3 seed types.(1) liver-kidney deficiency: SUN Si miao is once described as " it is read, the game person that excessively suffers from mesh, name day hepatic asthenia " to visual fatigue Referred to as " hepatic asthenia ".Chinese medicine thinks high myopic eye and its maculopathy is using liver-kidney deficiency as main pathogenesis.(2) deficiency-weakness of spleen-QI: The spleen has the function to transport and transform nutrients, is source of generating QI and blood, spleen fortune is healthy and vigorous, and eye obtains qi and blood vital essence and supports, then lustrous eyes;If spleen loses fortune, Loss of nutrient of eyes and blurred vision.Gu Piqiwang, then mesh is bright.(3) blood deficiency: blood master supports, and nutriment is transmitted whole body by blood, including Eye.Visual acuity is obtained from the sufficient blood supply of the eyes, blood deficiency, eyes losing nutrition then affect vision.So painstaking effort are sufficient, then mesh has mind.
It is mostly in the prior art Western medicine eye drops for the drug for alleviating visual fatigue, side effect is larger, and it is palliative, and The part population of eye sensitivity is inconvenient to use.
Summary of the invention
Present invention aims at provide to solve the problems, such as to alleviate the drug of asthenopia in the prior art A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation and preparation method thereof, which is by raw material fructus lycii, mulberry leaf, puncture Chenopodiaceae, chrysanthemum, Chinese yam, auxiliary material honey, white granulated sugar, sucrose, stevioside, lactose, potassium sorbate, essence, dextrin, starch, micro mist silicon Oral solution or tablet is made in glue, microcrystalline cellulose, sodium carboxymethylcellulose, Aspartame, magnesium stearate and crospovidone.This The invention compound preparation has kidney and spleen invigorating, and calming the liver and improving eyesight mitigates the effect of visual fatigue.Suitable for amblyope, as can compared with It takes for long periods of time, asthenopia symptom can be significantly improved and safety is without side-effects.
A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation of the present invention, said preparation are by raw material fructus lycii 220- 260g, mulberry leaf 190-250g, puncture vine 160-210g, chrysanthemum 50-110g, Chinese yam 140-180g, auxiliary material honey 100-160g, white sand Sugared 100-160g, sucrose 30-600g, stevioside 15-60g, lactose 30-600g, potassium sorbate 1-5g, essence 2-10mL, dextrin 30-600g, starch 30-600g, superfine silica gel powder 5-30g, microcrystalline cellulose 30-600g, sodium carboxymethylcellulose 5-30g, A Si Oral solution or tablet is made in Ba Tian 15-60g, magnesium stearate 5-30g and crospovidone 10-90g.
A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation, said preparation are by raw material fructus lycii 230-250g, mulberry leaf 200-230g, puncture vine 170-200g, chrysanthemum 70-100g, Chinese yam 150-170g, auxiliary material honey 120-150g, white granulated sugar 120- 150g, sucrose 30-600g, stevioside 15-60g, lactose 30-600g, potassium sorbate 2-4g, essence 6-8mL dextrin 100-500g, Starch 100-500g, superfine silica gel powder 10-20g, microcrystalline cellulose 100-500g, sodium carboxymethylcellulose 10-20g, Aspartame Oral solution or tablet is made in 20-50g, magnesium stearate 10-20g and crospovidone 20-80g.
A kind of preparation method of Traditional Chinese medicine for relieving vision fatigue compound preparation prepares 1000ml oral solution, specific to grasp It follows these steps to carry out:
A, required medicinal material is picked except impurity, cleaning is dried rear spare;
B, fructus lycii 220-260g, Chinese yam 140-180g are weighed, multi-function extractor is added, it is water-soluble with concentration 0-40% ethyl alcohol Liquid is as Extraction solvent, circumfluence distillation 2-3 times at 80-100 DEG C of temperature, each 1-2h, the mass ratio of raw material and extracting solution For 1:12-16, is filtered with 180 mesh nylon cloths, obtain extracting solution, it is spare;
C, mulberry leaf 190-250g, chrysanthemum 50-110g, puncture vine 160-210g are weighed, multi-function extractor is added, it is dense with volume Degree 40-60% ethanol water is as Extraction solvent, circumfluence distillation 2-3 times at 70-90 DEG C of temperature, each 1-2h, raw material Mass ratio with extracting solution is 1:12-16, is filtered with 180 mesh nylon cloths, obtains extracting solution, spare;
D, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 2-5% is added, stands 2-5h after being layered, uses plate and frame filter press It filters again;
E, the obtained filtrate of step d is concentrated into dry cream, is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, Routinely pharmaceutical methods are up to oral solution;
Or the obtained filtrate of step d is concentrated into dry cream, it is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, Honey 100-160g, white granulated sugar 100-160g, essence 2-10mL and potassium sorbate 1-5g is added to be uniformly mixed, routinely pharmacy side Method is up to oral solution.
A kind of preparation method of Traditional Chinese medicine for relieving vision fatigue compound preparation, prepares 1000g tablet, and concrete operations are pressed The following steps carry out:
A, fructus lycii 220-260g, Chinese yam 140-180g are weighed, multi-function extractor is added, it is water-soluble with concentration 0-40% ethyl alcohol Liquid is as Extraction solvent, circumfluence distillation 2-3 times at 80-100 DEG C of temperature, each 1-2h, the mass ratio of raw material and extracting solution For 1:12-16, is filtered with 180 mesh nylon cloths, obtain extracting solution;
B, mulberry leaf 190-250g, chrysanthemum 50-110g, puncture vine 160-210g are weighed, multi-function extractor is added, it is dense with volume Degree 40-60% ethanol water is as Extraction solvent, circumfluence distillation 2-3 times at 70-90 DEG C of temperature, each 1-2h, raw material Mass ratio with extracting solution is 1:12-16, is filtered with 180 mesh nylon cloths, obtains extracting solution;
C, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After layer medical fluid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 2-5% is added, stands 2-5h after being layered, uses plate compression Machine filters again;
D, the obtained filtrate of step c is concentrated into dry cream, crushed, it is spare to cross 80 meshes;
E, auxiliary material dextrin 30-600g, starch 30-600g, sucrose 30-600g, sweet tea is added in the dry cream powder for obtaining step d Synanthrin 15-60g, lactose 30-600g, superfine silica gel powder 5-30g, microcrystalline cellulose 30-600g, sodium carboxymethylcellulose 5-30g, Ah This Ba Tian 15-60g, magnesium stearate 5-30g, crospovidone 10-90g, essence 2-6mL, then plus concentration be 70-90% ethyl alcohol system Softwood, sieving granulation, then the drying in 40-50 DEG C of baking oven of temperature of wet grain will be made, whole grain of being sieved adds lubricant 1-5% to mix Uniformly, tabletting according to a conventional method to obtain the final product.
A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation of the present invention has kidney and spleen invigorating, and calming the liver and improving eyesight mitigates The effect of visual fatigue.
A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation of the present invention, each component performance is as follows in said preparation:
Fructus lycii, this product are the dry mature fruit of Lycium barbarum L. of solanaceae.Summer, Qiu Erji fruit are adopted when taking on a red color It receives, hot-air seasoning, removes carpopodium, or dry in the air to rhicnosis, dry, remove carpopodium.Property sweet and neutral.Return liver and kidney channel.Can be nourishing liver and kidney, Benefiting shrewd head;For consumption consumptive loss, soreness of waist and knee joint, dizziness and tinnitus, impotence and seminal emission, Heat Diabetes, blood deficiency chlorosis, blurred vision.
Mulberry leaf, this product are the dried leaf of moraceae plants mulberry.It is harvested after first frost, removes impurity, dry.Property it is sweet, bitter, tremble with fear.Return Lung, Liver Channel.Can dispelling wind and heat from the body, clearing away the lungheat and moisturizing clears liver and improve vision;For anemopyretic cold, lung-heat type cough, dizziness headache, red eyes and dim-sighted.
Puncture vine, this product are the dry mature fruit of zygophyllaceae plant puncture vine.Plant is tapped when the fruit matures in the fall, is dried, Fruit is laid, impurity is removed.Pungent, bitter, the tepor of property;It is slightly poisonous.Return liver warp.Can calming the liver and dispelling melancholy, promoting blood circulation by removing wind, improving eyesight is antipruritic;With In headache and dizziness, distending pain in the chest and hypochondrium, cream closes acute mastitis, cataract, rubella itch.
Chrysanthemum, this product are the dry capitulum of compositae plant chrysanthemum.It harvests, dry in the shade or roasts in batches when 9~November spends in full bloom It is dried after dry or smoked, steaming.Property is sweet, bitter, slightly cold.Return lung, Liver Channel.Can relieve heat heat-clearing, calming the liver and improving eyesight is clearing heat and detoxicating;For wind-heat Flu, headache and dizziness, red eye, swell pain, eyes is dim-sighted, sore and toxic.
Chinese yam, this product are the dry rhizome of Dioscoreaceae plant Chinese yam.It is excavated after winter cauline leaf is withered, cuts root head, cleaned, Crust and fibrous root are removed, it is dry, it practises and claims " hair yam slice ";Or crust is removed, and fresh-cut sheet is taken advantage of, it is dry, referred to as " yam slice ";? Have the loose straight drying Chinese yam of selection, set in clear water, be dipped into without the dry heart, it is bored, trim both ends, be twisted into plank it is cylindric, It dries, polishing, practises and claim " light yam ".Property sweet and neutral.Returns spleen, lung, kidney channel.Can tonifying spleen nourishing the stomach, engender liquid and benefic lung, kidney tonifying arresting seminal emission.For Spleen eating less, endless diarrhea, the deficiency syndrome of the lung are breathed with cough, emission due to the kidney deficiency, leukorrhagia, frequent micturition, and abnormal heat is quenched one's thirst.
A kind of Traditional Chinese medicine for relieving vision fatigue compound preparation of the present invention, fructus lycii in said preparation, mulberry leaf, puncture vine, Chrysanthemum etc. is nourishing liver and kidney, benefiting shrewd head, Chinese yam spleen-strengtheningporridge nourishing the stomach, kidney tonifying arresting seminal emission.By kidney and spleen invigorating, the drug of calming the liver and improving eyesight is matched It closes, visual fatigue and fundamentally nourishing liver and kidney can be mitigated.
Detailed description of the invention
Fig. 1 is influence of the oral solution of the present invention to muscle cell apoptosis;
Fig. 2 is A673 changes of cell apoptosis figure of the present invention.
Specific embodiment
Prepare oral solution:
Wash bottle is dry: taking low borosilicate glass bottle (specification 10mL), bottle stopper that drinking water, purified water is once used to clean, then will Low borosilicate glass bottle hot air sterilization, bottle stopper boiling water boiling sterilize 30min, it is spare;
Filling, tamponade: opening machine, and adjustment filling amount is 10mL/ bottles, and semi-finished product oral solution is filled in automatic filling and sealing machine Dress, tamponade, and check the leakproofness of tamponade;
Sterilizing: by canned oral solution high pressure steam sterilization, 115 DEG C of temperature, time 30min;
Lamp inspection: failed test sample is rejected, the special container of unqualified mark is deposited in;
Packaging, product inspection, storage;
Production is clean to be required: reaching 300,000 grades of cleanliness with liquid, filtering, filling, tamponade operating environment requirement.
Embodiment 1
1000ml oral solution is prepared, concrete operations follow these steps to carry out:
A, required medicinal material is picked except impurity, cleaning is dried rear spare;
B, fructus lycii 220g, Chinese yam 140g are weighed, multi-function extractor is added, use 0% dehydrated alcohol of concentration molten as extracting The mass ratio of agent, the circumfluence distillation 2 times at 80 DEG C of temperature, each 1h, raw material and extracting solution is 1:12, with 180 mesh nylon cloths Filtering, obtains extracting solution, spare;
C, mulberry leaf 190g, chrysanthemum 50g, puncture vine 160g are weighed, multi-function extractor is added, with 40% ethanol water of volumetric concentration Solution is as Extraction solvent, circumfluence distillation 2 times under temperature 70 C, each 1h, and the mass ratio of raw material and extracting solution is 1:12, It is filtered with 180 mesh nylon cloths, obtains extracting solution, it is spare;
D, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 2% is added, stands 2-5h after being layered, again with plate and frame filter press Secondary filtering;
E, the obtained filtrate of step d is concentrated into dry cream, is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, Routinely pharmaceutical methods are up to oral solution.
Embodiment 2
1000ml oral solution is prepared, concrete operations follow these steps to carry out:
A, required medicinal material is picked except impurity, cleaning is dried rear spare;
B, fructus lycii 240g, Chinese yam 160g are weighed, multi-function extractor is added, use 10% ethanol water of concentration as extraction The mass ratio of solvent, the circumfluence distillation 3 times at 90 DEG C of temperature, each 2h, raw material and extracting solution is 1:14, with 180 mesh nylon Cloth filtering, obtains extracting solution, spare;
C, mulberry leaf 220g, chrysanthemum 80g, puncture vine 180g are weighed, multi-function extractor is added, with 50% ethanol water of volumetric concentration Solution is as Extraction solvent, the circumfluence distillation 3 times at 80 DEG C of temperature, each 2h, and the mass ratio of raw material and extracting solution is 1:14, It is filtered with 180 mesh nylon cloths, obtains extracting solution, it is spare;
D, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 3% is added, stands 3h after being layered, again with plate and frame filter press Filtering;
E, the obtained filtrate of step d is concentrated into dry cream, is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, Routinely pharmaceutical methods are up to oral solution.
Embodiment 3
1000ml oral solution is prepared, concrete operations follow these steps to carry out:
A, required medicinal material is picked except impurity, cleaning is dried rear spare;
B, fructus lycii 260g, Chinese yam 180g are weighed, multi-function extractor is added, use 30% ethanol water of concentration as extraction The mass ratio of solvent, the circumfluence distillation 3 times at 100 DEG C of temperature, each 2h, raw material and extracting solution is 1:16, with 180 mesh nylon Cloth filtering, obtains extracting solution, spare;
C, mulberry leaf 250g, chrysanthemum 110g, puncture vine 210g are weighed, multi-function extractor is added, with 60% ethanol water of volumetric concentration Solution is as Extraction solvent, the circumfluence distillation 3 times at 90 DEG C of temperature, each 2h, and the mass ratio of raw material and extracting solution is 1:16, It is filtered with 180 mesh nylon cloths, obtains extracting solution, it is spare;
D, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 4% is added, stands 5h after being layered, again with plate and frame filter press Filtering;
E, the obtained filtrate of step d is concentrated into dry cream, is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, Routinely pharmaceutical methods are up to oral solution.
Embodiment 4
1000ml oral solution is prepared, concrete operations follow these steps to carry out:
A, required medicinal material is picked except impurity, cleaning is dried rear spare;
B, fructus lycii 250g, Chinese yam 150g are weighed, multi-function extractor is added, use 40% ethanol water of concentration as extraction The mass ratio of solvent, the circumfluence distillation 2 times at 85 DEG C of temperature, each 1h, raw material and extracting solution is 1:12, with 180 mesh nylon Cloth filtering, obtains extracting solution, spare;
C, mulberry leaf 200g, chrysanthemum 90g, puncture vine 200g are weighed, multi-function extractor is added, with 60% ethanol water of volumetric concentration Solution is as Extraction solvent, the circumfluence distillation 2 times at 90 DEG C of temperature, each 1h, and the mass ratio of raw material and extracting solution is 1:12, It is filtered with 180 mesh nylon cloths, obtains extracting solution, it is spare;
D, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid medicine concentration, the ZTC1+1 natural clarifying agent of stock solution quality 5% is added, stands 2h after being layered, again with plate and frame filter press Secondary filtering;
E, the obtained filtrate of step d is concentrated into dry cream, is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, Honey 100g, white granulated sugar 100g, essence 2mL and potassium sorbate 1g is added to be uniformly mixed, routinely pharmaceutical methods are up to oral solution.
Embodiment 5
1000ml oral solution is prepared, concrete operations follow these steps to carry out:
A, required medicinal material is picked except impurity, cleaning is dried rear spare;
B, fructus lycii 220g, Chinese yam 170g are weighed, multi-function extractor is added, use 0% dehydrated alcohol of concentration molten as extracting The mass ratio of agent, the circumfluence distillation 3 times at 90 DEG C of temperature, each 2h, raw material and extracting solution is 1:13, with 180 mesh nylon cloths Filtering, obtains extracting solution, spare;
C, mulberry leaf 220g, chrysanthemum 100g, puncture vine 200g are weighed, multi-function extractor is added, with 45% ethanol water of volumetric concentration Solution is as Extraction solvent, the circumfluence distillation 3 times at 75 DEG C of temperature, each 2h, and the mass ratio of raw material and extracting solution is 1:13, It is filtered with 180 mesh nylon cloths, obtains extracting solution, it is spare;
D, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 4% is added, stands 4h after being layered, again with plate and frame filter press Filtering;
E, the obtained filtrate of step d is concentrated into dry cream, is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, Honey 140g, white granulated sugar 140g, essence 5mL and potassium sorbate 3g is added to be uniformly mixed, routinely pharmaceutical methods are up to oral solution.
Embodiment 6
1000ml oral solution is prepared, concrete operations follow these steps to carry out:
A, required medicinal material is picked except impurity, cleaning is dried rear spare;
B, fructus lycii 260g, Chinese yam 140g are weighed, multi-function extractor is added, use 20% ethanol water of concentration as extraction The mass ratio of solvent, the circumfluence distillation 3 times at 100 DEG C of temperature, each 1h, raw material and extracting solution is 1:16, with 180 mesh nylon Cloth filtering, obtains extracting solution, spare;
C, mulberry leaf 250g, chrysanthemum 110g, puncture vine 210g are weighed, multi-function extractor is added, with 50% ethanol water of volumetric concentration Solution is as Extraction solvent, the circumfluence distillation 3 times at 90 DEG C of temperature, each 2h, and the mass ratio of raw material and extracting solution is 1:16, It is filtered with 180 mesh nylon cloths, obtains extracting solution, it is spare;
D, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 5% is added, stands 5h after being layered, again with plate and frame filter press Filtering;
E, the obtained filtrate of step d is concentrated into dry cream, is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, Honey 160g, white granulated sugar 160g, essence 10mL and potassium sorbate 5g is added to be uniformly mixed, routinely pharmaceutical methods are up to oral Liquid.
Embodiment 7
1000g tablet is prepared, concrete operations follow these steps to carry out:
A, fructus lycii 220g, Chinese yam 180g are weighed, circumfluence distillation is carried out using multi-function extractor, with the anhydrous second of concentration 0% Alcohol is as Extraction solvent, the circumfluence distillation 2 times at 80 DEG C of temperature, each 1h, and the mass ratio of raw material and extracting solution is 1:12, uses The filtering of 180 mesh nylon cloths, obtains extracting solution, spare;
B, weighing mulberry leaf 190g, chrysanthemum 110g, puncture vine 210g uses 40% ethanol water of volumetric concentration as Extraction solvent, The mass ratio of circumfluence distillation 2 times under temperature 70 C, each 1h, raw material and extracting solution is 1:12, with 180 mesh nylon cloth mistakes Filter, obtains extracting solution, spare;
C, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 2% is added, stands 2h after being layered, again with plate and frame filter press Filtering;
D, the obtained filtrate of step c is concentrated into dry cream, crushed, it is spare to cross 80 meshes;
E, auxiliary material dextrin 30g, starch 30g, sucrose 30g, stevioside 15g, lactose is added in the dry cream powder for obtaining step d 30g, superfine silica gel powder 5g, microcrystalline cellulose 30g, sodium carboxymethylcellulose 5g, Aspartame 15g, magnesium stearate 5g, the poly- dimension of crosslinking Ketone 10g, essence 2mL, then plus concentration be 70% ethyl alcohol softwood, then wet grain will be made in 40 DEG C of baking ovens of temperature in sieving granulation Dry, whole grain of being sieved adds lubricant 1% to be uniformly mixed, and tabletting according to a conventional method to obtain the final product.
Embodiment 8
1000g tablet is prepared, concrete operations follow these steps to carry out:
A, fructus lycii 240g, Chinese yam 160g are weighed, multi-function extractor is added, use 20% ethanol water of concentration as extraction The mass ratio of solvent, the circumfluence distillation 3 times at 90 DEG C of temperature, each 2h, raw material and extracting solution is 1:14, with 180 mesh nylon Cloth filtering, obtains extracting solution, spare;
B, weighing mulberry leaf 180g, chrysanthemum 80g, puncture vine 180g uses 50% ethanol water of volumetric concentration as Extraction solvent, The mass ratio of the circumfluence distillation 3 times at 80 DEG C of temperature, each 2h, raw material and extracting solution is 1:14, with 180 mesh nylon cloth mistakes Filter, obtains extracting solution, spare;
C, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After clear liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 5% is added, stands 5h after being layered, again with plate and frame filter press Filtering;
D, the obtained filtrate of step c is concentrated into dry cream, crushed, it is spare to cross 80 meshes;
E, the dry cream powder obtained step d be added auxiliary material dextrin 200g, starch 200g, sucrose 200g, stevioside 30g, Lactose 200g, superfine silica gel powder 20g, microcrystalline cellulose 200g, sodium carboxymethylcellulose 20g, Aspartame 30g, magnesium stearate 15g, crospovidone 50g, essence 6mL, then plus concentration be 90% ethyl alcohol softwood, then wet grain will be made in temperature in sieving granulation Spend in 50 DEG C of baking ovens dry, whole grain of being sieved adds lubricant 3% to be uniformly mixed, and tabletting according to a conventional method to obtain the final product.
Embodiment 9
1000g tablet is prepared, concrete operations follow these steps to carry out:
A, fructus lycii 260g, Chinese yam 140g are weighed, multi-function extractor is added, use 40% ethanol water of concentration as extraction The mass ratio of solvent, the circumfluence distillation 3 times at 100 DEG C of temperature, each 1h, raw material and extracting solution is 1:16, with 180 mesh nylon Cloth filtering, obtains extracting solution, spare;
B, weighing mulberry leaf 250g, chrysanthemum 50g, puncture vine 160g uses 60% ethanol water of volumetric concentration as Extraction solvent, The mass ratio of the circumfluence distillation 2 times at 90 DEG C of temperature, each 2h, raw material and extracting solution is 1:16, with 180 mesh nylon cloth mistakes Filter, obtains extracting solution, spare;
C, the filtrate of step b and step c are merged, stands for 24 hours, leaves and takes supernatant after being filtered with plate and frame filter press, it will be upper After layer medical fluid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 4% is added, stands 4h after being layered, again with plate and frame filter press Secondary filtering;
D, the obtained filtrate of step c is concentrated into dry cream, crushed, it is spare to cross 80 meshes;
E, the dry cream powder obtained step d be added auxiliary material dextrin 600g, starch 600g, sucrose 600g, stevioside 60g, Lactose 600g, superfine silica gel powder 30g, microcrystalline cellulose 600g, sodium carboxymethylcellulose 30g, Aspartame 60g, magnesium stearate 30g, crospovidone 90g, essence 5mL, then plus concentration be 80% ethyl alcohol softwood, then wet grain will be made in temperature in sieving granulation Spend dry in 40-50 DEG C of baking oven, whole grain of being sieved adds lubricant 5% to be uniformly mixed, and tabletting according to a conventional method to obtain the final product.
Embodiment 10
Any one Traditional Chinese medicine for relieving vision fatigue compound preparation obtained by embodiment 1-9 is subjected to effect experiment:
Acute toxicity test:
KM mouse, Xinjiang Animal Experimental Study center provide, production licence number: SCXK (new) 2016-0001, using perhaps It can the number of card: SYXK (new) 2014-0002;
Mtd test (MTD): selection healthy mice 20, half male and half female, 22.4 ± 1.1g of weight, fasting 24 are small When, compound preparation oral solution, which is concentrated into, to press 0.2ml/10g stomach-filling with the maximum concentration of stomach-filling with maximum concentration, early, evening is respectively Stomach-filling is primary, is observed continuously 14 days, as a result test mice spirit and active state are without exception, also without death;It is small at the end of experiment Mouse average weight is 32.1 ± 2.1g, by dissection, the main organs no abnormality seen such as mouse core, liver, spleen, lung, kidney;Therefore compound system The maximal tolerance dose of agent oral solution is 36.7g/kg;The MTD of mouse ig administration is 36.7g/kg, and being equivalent to adult, (weight is pressed 70kg meter) 16.2 times of dosage daily, prompt this preparation without overt toxicity, drug safety;
Pharmacodynamic test:
1. pharmacodynamic test in body:
1.1 experimental methods:
1.1.1 animal packet and administration:
It chooses 90 ICR mouse and is randomly divided into normal group by weight, negative control group, Nuodikang group, compound preparation is oral Liquid water extraction/ethanol extract low, middle and high dose groups, every group is 10;Normal group is not processed, negative control group with The distilled water stomach-filling of 0.2ml/10g, Nuodikang group is with the Nuodikang stomach-filling of 0.28g/kg, compound preparation oral solution water extract Respectively with the composition stomach-filling of 0.1082,0.541 and 1.082g/kg, compound preparation oral solution ethyl alcohol mentions low, middle and high dose groups Take object low, middle and high dose groups respectively with the composition stomach-filling of 0.0861,0.4305 and 0.861g/kg, 1 times/day, continuous gavage 14 days;All drugs are suspended with distilled water, weigh mouse weight every 2d during administration;
1.1.2 tired transfer rod detection:
It is opened within the 13rd day in each groups ICR intragastric administration on mice such as negative control group, Nuodikang group and compound preparation oral solution administration groups The fatigue that begins transfer rod detection except for the normal group, remaining each group mouse is placed in tired transfer rod instrument and is instructed with 20rpm after 30min is administered Practice 3min, the time is still then fallen with the Rotating speed measring mouse of 20rpm, as tired incubation period (s);
1.1.3 swimming with a load attached to the body detects:
After mouse last stomach-filling 30min, except for the normal group, remaining mouse 5% weight of load at away from root of the tail portion 1cm Sheet lead, it is 37 × 37 × 50cm, depth of water 40cm, the swimming trunk went swimming that water temperature is 25 ± 1 DEG C that mouse, which is then placed in volume,;It puts Timing immediately after Yu Shuizhong, until mouse head does not have upstream face 10s to be unable to emersion, as mouse power exhausts the time (min);
1.1.4 influence of the compound preparation to mouse heart, liver, kidney, thymus gland and spleen weight:
Swimming with a load attached to the body detection is completed and is plucked after eyeball takes blood, and mouse takes off strength and puts to death, conventional solution take mouse heart, liver, Kidney, thymus gland and spleen calculate dirty body ratio;
1.1.5 influence of the compound preparation to mouse related biochemical indicator:
After the completion of swimming with a load attached to the body detection, eyeball is plucked after mouse rest 30min and takes blood, be placed in heparin sodium anticoagulant tube and non-anticoagulant Pipe.Heparin sodium anticoagulation is for measuring hemoglobin, and then remaining blood sample is centrifuged 10min with 3500rpm, separates serum or blood Slurry measures LD, LDH, ROS, SOD, MDA, testosterone, cortisone, BUN.Mouse after taking blood takes liver and gastrocnemius through physiology It is blotted after saline rinse with filter paper, accurately weighs liver, muscle, measure the hepatic glycogen in liver and the inose in musculature Original, CK, LDH, MDH, SDH;
1.1.6 influence of the compound preparation to Muscle Tissue Apoptosis:
Musculature 0.1g is weighed, 400 μ l cell pyrolysis liquids are added, adds 100 μ l of Proteinase K after mixing well again, sets temperature 65 DEG C of water-baths are spent to digest 2 hours or overnight, sequentially add the potassium acetate of 75 μ l 8mol/L, 4 DEG C of 15min of temperature, then plus 750 μ L chloroform, after mixing well, 10000r/min be centrifuged after ten minutes, supernatant is moved in a new Eppendorf pipe, then plus Enter 750 μ l dehydrated alcohols, upper and lower gentle inversion mixing, i.e., visible milky white precipitate, if -20 DEG C of mistakes of temperature can be set when unobvious Night, 12000r/min are centrifuged 10 minutes, remove supernatant;Add 1ml70% ethyl alcohol, mix, 10000r/min is centrifuged 5min, removes supernatant; According to the size that DNA is precipitated, a certain amount of distilled water or TE is added, 37 DEG C of temperature dissolve, with 2% agar after measurement DNA concentration Sugared gel electrophoresis 80V 2 hours, takes pictures under gel imaging system;
1.1.7 influence of the compound preparation to mouse muscle related gene transcriptional level:
Musculature 0.1g is weighed, extracts RNA in musculature using Trizol method, electrophoresis verifies the integrality of RNA;It is logical The AMV reverse transcription reagent box for crossing TAKARA company carries out reverse transcription reaction;Use QIAquickPCR Purification Kit Carry out cDNA purifying;Purifying cDNA is done into gradient dilution by 1 times, 1/2 times, 1/4 times, 1/8 times, 1/16 times and 1/32 times concentration, It usesGreen qPCR SuperMix-UDG reagent (invitrogen) carries out Realtime PCR (Bio-Rad CFX96) generate MDH, LDH, SDH, AMPK, PGC-1 α, PFK-1, Nrf2, Keap1, CYP11A1, CYP17A1, CYP11B1, the isogenic standard curve of Bcl-2, Bax, Cleaved caspase-3, P53;Quantitative expression result is according to CT number Value, according to 2'- Δ Δ Ct method, calculates its relative expression quantity;2-ΔΔC T=[(CT gene of interest-CT internal control)]sampleA-[(CT gene of interest–CT internal control)]sampleB;
1.2 results and analysis:
1.2.1 to the influence of mouse weight:
As shown in Table 1, compared with normal group and negative control group, after Nuodikang and compound oral solutions gastric infusion 0d, 3d, 6d, 9d, 12d and 14d, there was no significant difference for mouse weight (p > 0.05);
The variation of 1 mouse weight of table (N=10)
Note: compared with negative control group,*P ﹤ 0.05,**P ﹤ 0.01;
1.2.2 the influence to mouse heart, liver, kidney, thymus gland and spleen weight:
As shown in Table 2, compared with normal group and negative control group, Nuodikang and the administration of compound preparation oral solution continuous gavage After 14d, mouse heart index, liver index, renal index, index and spleen index and thymus index there are no significant difference (p > 0.05);
2 mouse heart of table, liver, kidney, Thymus and spleen index (N=10)
Note: compared with negative control group,*P ﹤ 0.05,**P ﹤ 0.01;
1.2.3 the influence of time is exhausted to mouse fatigue transfer rod and swimming with a load attached to the body power:
As shown in Table 3, compared with negative control group, compound preparation oral solution water extract, alcohol extract and Nuodikang administration group It can conspicuousness extension mice burden swimming time and tired transfer rod time;
3 mice burden swimming of table and tired transfer rod time (N=10)
Note: compared with negative control group,*P ﹤ 0.05,**P ﹤ 0.01;
1.2.4 the influence to Hb, LD, LDH, ROS, SOD, MDA, T/C, BUN, CK in mice serum (slurry) etc.:
As shown in Table 4, compared with normal group, negative control group mouse is after swimming with a load attached to the body, hemoglobin (Hb), super oxygen Compound mutase (SOD), testosterone/cortisone (T/C) ratio, creatine kinase (CK) equal size (activity) are substantially reduced, and lactic acid (LD), active oxygen (ROS), lactic dehydrogenase (LDH), malonaldehyde (MDA) and plasma urea nitrogen (BUN) content significantly increase.With Negative control group compares, and compound preparation oral solution water extract and alcohol extract administration group mouse Hb, SOD, T/C, CK etc. significantly increase, LD, ROS, LDH, MDA and BUN are substantially reduced;
Table 4 compound preparation Oral Liquid On Mice serum (slurry) biochemical indicator influence (N=10)
Note: compared with negative control group,*P ﹤ 0.05,**P ﹤ 0.01;
1.2.5 the influence to CK, hepatic glycogen, muscle glycogen, LD, LDH, MDH and SDH etc. in mouse tissue:
As shown in Table 5, compared with normal group, negative control group mouse is after swimming with a load attached to the body, CK, inose in musculature Original, SDH, MDH and hepatic glycogen etc. reduce, and LD content increases, but LDH activity is without significant change;It is multiple compared with negative control group Square preparation oral solution and Nuodikang administration group can be such that CK in Muscle Tissue, muscle glycogen, SDH, MDH and hepatic glycogen increases, LD is substantially reduced.
Table 5 compound preparation Oral Liquid On Mice serum (slurry) biochemical indicator influence (N=10)
Note: compared with negative control group,*P ﹤ 0.05,**P ﹤ 0.01.
1.2.6 influence of the compound preparation oral solution water extract to mouse muscle Apoptosis:
For the gastrocnemius genomic DNA of extraction after 2% agarose gel electrophoresis, normal group cell genomic dna is more complete It is whole, and there is ladder-like DNA not of uniform size in negative control group swimming lane, molecular weight is in 200bp-200n bp;Through various concentration After the effect of Traditional Chinese medicine for relieving vision fatigue compound preparation oral solution, ladder-like DNA is gradually decreased, especially with water extract middle dosage work With the most obviously;This shows that Traditional Chinese medicine for relieving vision fatigue compound preparation oral solution water extract withers to the myocyte of injury gained in sports Die inhibited (Fig. 1);
1.2.7 influence of the compound preparation oral solution water extract to Muscle Tissue related gene mRNA transcriptional level:
By data analysis in table 6 it is found that compared with negative control group, mouse Nuodikang and Traditional Chinese medicine for relieving vision fatigue are multiple After square preparation oral solution water extract gastric infusion, musculature Bax, cleaved caspase-3, P53, CYP11B and The gene transcription levels such as LDH are significantly lowered;And Bcl-2, Keap1, Bach, Nrf2, PGC-1 α, PFK-1, CYP17A1, The gene levels such as CYP11A1, MDH and SDH are significantly raised;
6 compound preparation Oral Liquid On Mice musculature related gene of table transcription influence (N=10)
Note: compared with negative control group,*P ﹤ 0.05,**P ﹤ 0.01;
2. pharmacy in vitro is tested:
2.1 experimental methods:
2.1.1A-673 the culture of cell:
By A-673 cell with 5 × 105A/ml is inoculated in the NaHCO containing 10% fetal calf serum, 1.5g/L3, 100U/ml it is green In the DMEM culture medium of mycin and 100U/ml streptomysin, 37 DEG C are placed in, the CO of volume fraction 5%2It is cultivated in incubator, every 3 It changes a not good liquor;
2.1.2 cell oxidative damage model foundation and cell administration:
When A-673 cell confluency reaches 80% or so in culture bottle, with the RPMI for containing 10% fetal calf serum (FBS) DMEM culture medium is blown and beaten, and adjusts cell density to 5 × 104A/ml is spread to 96 well culture plates with 100 holes μ l/, cultivates 48h Grouping administration afterwards, is set separately: Normal group, model group, positive drug group, compound preparation low, middle and high dose groups;Model group With the H of 400 μM/L2O2Induction;Positive drug is the Vitmin E solution of 4.3mg/L (10 μM/L);Compound preparation administration concentration are as follows: 10,100,1000mg/L;After each administration group effect for 24 hours, MTT is added, continues to cultivate 4h, inhales and abandon culture solution, DMSO concussion is added After dissolution, the absorbance value at 1510 microplate reader of Multiskan Go measurement 490nm;
2.1.3 the influence to cell LDH, ROS, MDA, SOD:
After cell administration processing, cell culture supernatant is collected, referring to LDH enzyme activity in kit specification measurement culture solution Property, ROS content, MDA content and SOD activity;
2.1.4 data processing: data withIt indicates, is handled using SPSS17.0 statistical software, use one-way ANOVA carries out comparison among groups;
2.2 results and analysis:
2.2.1 the influence to cell LDH, ROS, MDA, SOD:
As shown in Table 7, H of the A-673 cell through 400 μM/L2O2After induction for 24 hours, cell LDH, ROS and MDA are significantly raised, SOD activity reduces;And cell LDH, ROS and MDA are significantly reduced after compound preparation and vit E effect, SOD activity is significantly raised;
LDH, SOD activity and ROS, MDA content in 7 A-673 cell supernatant of table
Note: compared with normal group,P ﹤ 0.05,△△P ﹤ 0.01;Compared with negative control group,*P ﹤ 0.05,**P ﹤ 0.01;
2.2.2 to the influence of Apoptosis:
By table 8 and Fig. 2 it is found that H of the A-673 cell through 400 μM/L2O2After induction for 24 hours, early stage Apoptosis ratio calibration Often group increases, and cell early stage Apoptosis ratio is significantly reduced compared with negative control group after composition and vit E effect;
A. D.10mg/L E.100mg/L F.1000mg/L composition combines composition normal B. feminine gender C.vit E Object;
8 A673 changes of cell apoptosis of table
Note: compared with normal group,P ﹤ 0.05,△△P ﹤ 0.01;Compared with negative control group,*P ﹤ 0.05,**P ﹤ 0.01.

Claims (4)

1. a kind of Traditional Chinese medicine for relieving vision fatigue compound preparation, it is characterised in that said preparation is by raw material fructus lycii 220-260g, mulberry Leaf 190-250g, puncture vine 160-210g, chrysanthemum 50-110g, Chinese yam 140-180g, auxiliary material honey 100-160g, white granulated sugar 100- 160g, sucrose 30-600g, stevioside 15-60g, lactose 30-600g, potassium sorbate 1-5g, essence 2-10mL, dextrin 30- 600g, starch 30-600g, superfine silica gel powder 5-30g, microcrystalline cellulose 30-600g, sodium carboxymethylcellulose 5-30g, Aspartame Oral solution or tablet is made in 15-60g, magnesium stearate 5-30g and crospovidone 10-90g.
2. a kind of Traditional Chinese medicine for relieving vision fatigue compound preparation according to claim 1, it is characterised in that said preparation be by Raw material fructus lycii 230-250g, mulberry leaf 200-230g, puncture vine 170-200g, chrysanthemum 70-100g, Chinese yam 150-170g, auxiliary material honey 120-150g, white granulated sugar 120-150g, sucrose 30-600g, stevioside 15-60g, lactose 30-600g, potassium sorbate 2-4g, perfume (or spice) Smart 6-8mL dextrin 100-500g, starch 100-500g, superfine silica gel powder 10-20g, microcrystalline cellulose 100-500g, carboxymethyl cellulose Oral solution or tablet is made in plain sodium 10-20g, Aspartame 20-50g, magnesium stearate 10-20g and crospovidone 20-80g.
3. a kind of preparation method of Traditional Chinese medicine for relieving vision fatigue compound preparation according to claim 1 or 2, feature exist In preparation 1000ml oral solution, concrete operations follow these steps to carry out:
A, required medicinal material is picked except impurity, cleaning is dried rear spare;
B, weigh fructus lycii 220-260g, Chinese yam 140-180g be added multi-function extractor, use concentration 0-40% ethanol water as The mass ratio of Extraction solvent, circumfluence distillation 2-3 times at 80-100 DEG C of temperature, each 1-2h, raw material and extracting solution is 1:12- 16, it is filtered with 180 mesh nylon cloths, obtains extracting solution, it is spare;
C, mulberry leaf 190-250g, chrysanthemum 50-110g, puncture vine 160-210g are weighed, multi-function extractor is added, with volumetric concentration 40- 60% ethanol water is as Extraction solvent, circumfluence distillation 2-3 times at 70-90 DEG C of temperature, each 1-2h, raw material and extraction The mass ratio of liquid is 1:12-16, is filtered with 180 mesh nylon cloths, obtains extracting solution, spare;
D, the filtrate of step b and step c are merged, stands for 24 hours, supernatant is left and taken after being filtered with plate and frame filter press, by upper layer medicine After liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 2-5% is added, stands 2-5h after being layered, again with plate and frame filter press Filtering;
E, the obtained filtrate of step d is concentrated into dry cream, is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, by normal Pharmaceutical methods are advised up to oral solution;
Or the obtained filtrate of step d is concentrated into dry cream, it is dissolved to 8.8g/10mL containing crude drug amount with purified water after crushing, is added Honey 100-160g, white granulated sugar 100-160g, essence 2-10mL and potassium sorbate 1-5g are uniformly mixed, and routinely pharmaceutical methods are Obtain oral solution.
4. a kind of preparation method of Traditional Chinese medicine for relieving vision fatigue compound preparation according to claim 1 or 2, feature exist In preparation 1000g tablet, concrete operations follow these steps to carry out:
A, weigh fructus lycii 220-260g, Chinese yam 140-180g be added multi-function extractor, use concentration 0-40% ethanol water as The mass ratio of Extraction solvent, circumfluence distillation 2-3 times at 80-100 DEG C of temperature, each 1-2h, raw material and extracting solution is 1:12- 16, it is filtered with 180 mesh nylon cloths, obtains extracting solution, it is spare;
B, mulberry leaf 190-250g, chrysanthemum 50-110g, puncture vine 160-210g are weighed, multi-function extractor is added, with volumetric concentration 40- 60% ethanol water is as Extraction solvent, circumfluence distillation 2-3 times at 70-90 DEG C of temperature, each 1-2h, raw material and extraction The mass ratio of liquid is 1:12-16, is filtered with 180 mesh nylon cloths, obtains extracting solution, spare;
C, the filtrate of step b and step c are merged, stands for 24 hours, supernatant is left and taken after being filtered with plate and frame filter press, by upper layer medicine After liquid concentration, the ZTC1+1 natural clarifying agent of stock solution quality 2-5% is added, stands 2-5h after being layered, again with plate and frame filter press Filtering;
D, the obtained filtrate of step c is concentrated into dry cream, crushed, it is spare to cross 80 meshes;
E, auxiliary material dextrin 30-600g, starch 30-600g, sucrose 30-600g, stevioside is added in the dry cream powder for obtaining step d 15-60g, lactose 30-600g, superfine silica gel powder 5-30g, microcrystalline cellulose 30-600g, sodium carboxymethylcellulose 5-30g, A Siba Sweet tea 15-60g, magnesium stearate 5-30g, crospovidone 10-90g, essence 2-6mL, then plus concentration be 70-90% ethyl alcohol softwood, Sieving granulation, then the drying in 40-50 DEG C of baking oven of temperature of wet grain will be made, whole grain of being sieved adds lubricant 1-5% to be uniformly mixed, presses Conventional method tabletting to obtain the final product.
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